A Randomised, International, Multicenter Study to assess the Efficacy and Safety of Mesalazine EC tablets 500 mg (4.5g/daily) and Salofalk® tablets 500 mg (4.5 g/daily) in the Treatment of Moderate Active Crohn disease
- Conditions
- Moderate active Crohn disease
- Registration Number
- EUCTR2004-004083-77-CZ
- Lead Sponsor
- Disphar International B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 436
To participate in this trial, patients will have to meet all of the following criteria:
-established diagnosis of Crohn disease in Moderate active status verified by clinical evaluation, laboratory tests and by X-ray examination or/and colonoscopy and histology
-Crohn disease of at least 3 months duration
-acute exacerbation of moderate Crohn disease with a CDAI score between 220–400 points
-patients between 18–75 years, both sexes
-written informed consent obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients meeting any of the following criteria will be excluded from participation in this study:
-positive stool culture for enteric pathogens including Salmonella, Shigella, Yersinia or Campylobacter
-pregnant or lactating women
-women of child bearing potential not taking adequate contraceptive precautions
-maintenance treatment with higher daily doses (orally or rectally) than 4 g of Sulfasalazine or 2 g of Mesalazine EC 500 mg or any derivative up to one month before entering the study
-chronic use of any anti-inflammatory drugs, including NSAID´s (rectally or orally) within 7 days prior to inclusion; chronic use is defined as intake of medication every day for more than 7 consecutive days
-chronic administration of any steroids is an exclusion criterion within 7 days before entering the study
-chronic administration of any immunosuppressive agents is an exclusion criterion within 3 months before entering the study
-any other disease or condition which may interfere with study assessments as judged by the investigator
-alcohol or drug abuse
-patients taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months
-patients allergic to aspirin or other salicylates
-clinically significant renal/hepatic impairment or serious heartdisease
-patients presenting any malignant disease
-patients likely not to comply with the study procedures
-patients with any kind of stomy and after subtotal colectomy and with ileorectal anastomosis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if the study drug (Mesalazine EC tablets 500 mg) is at least as effective (non-inferiority testing) as the comparative medication (Salofalk® tablets 500 mg) in the common dose regimen 3× 3 tbl (= 4.5 g/daily) based on remission rate in both groups. ;Secondary Objective: To determine the safety and tolerability of Mesalazine EC tablets 500 mg.;Primary end point(s): Proportions of patients considered to have achieved clinical remission (final CDAI score < 150 points).
- Secondary Outcome Measures
Name Time Method